An International Pulmonary Embolism Registry Using EKOS

NCT ID: NCT03426124

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-09-30

Brief Summary

This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

Detailed Description

For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site.

For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.

Conditions

Pulmonary Embolism and Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic

Intervention Type: DEVICE

The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Prospective

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic

Intervention Type: DEVICE

The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Interventions

EkoSonic Endovascular System with thrombolytic

The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Intervention Type: DEVICE

Other Intervention Names

Acoustic Pulse Thrombolysis; EKOS

Eligibility Criteria

Inclusion Criteria

• Treated with APT procedure between January 1, 2014 and one year prior to site activation
• RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
• PE symptom duration ≤ 14 days
• Troponin elevation

• Male or female ≥ 18 years of age and ≤ 80 years of age
• RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
• PE symptom duration ≤ 14 days
• Troponin elevation
• Signed informed consent obtained from participant or legally authorized representative
• Investigator has selected the EKOS device to treat participant with massive or submassive pulmonary embolism

Exclusion Criteria

• Enrollment into the OPTALYSE PE study

• High-risk for catastrophic bleeding
• Life expectancy < one year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Sterling, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Alexandria Hospital

Locations

Healthfinity, PLLC Advanced Cardiac & Vascular Clinic

Glendale, Arizona, United States

Cedars - Sinai

Los Angeles, California, United States

Radiology Imaging Associates

Englewood, Colorado, United States

Bradenton Cardiology Center

Bradenton, Florida, United States

Delray Medical Center

Delray Beach, Florida, United States

St. Vincent's Healthcare

Jacksonville, Florida, United States

University of Florida

Jacksonville, Florida, United States

Memorial Hospital

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

Tallahassee Research Institute, Inc

Tallahassee, Florida, United States

AdventHealth Tampa Pepin Heart Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

WellStar Medical Group

Marietta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

St. Mary Medical Center

Hobart, Indiana, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

St. Elizabeth Healthcare

Crestview Hills, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Jewish Hospital

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

St. Vincent Hospital/Reliant Medical Group

Worcester, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Metro Health - University of Michigan Health

Wyoming, Michigan, United States

Cardiology Associates of Northern Mississippi

Oxford, Mississippi, United States

Saint Louis University Hospital

St Louis, Missouri, United States

Dartmouth - Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper University Healthcare

Camden, New Jersey, United States

University of Buffalo

Buffalo, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Summa Health

Akron, Ohio, United States

Mercy Health Cincinnati

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

TriHealth Good Samaritan Bethesda North

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Mount Caramel East Hospital

Columbus, Ohio, United States

University of Toledo

Toledo, Ohio, United States

Genesis Healthcare System

Zanesville, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

St. Vincent Hospital, Allegheny Health Network

Erie, Pennsylvania, United States

Temple University Hospital, Department of Thoracic Medicine & Surgery

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Hamot

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Lexington Cardiology

West Columbia, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Hendrick Medical Center

Abilene, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Houston Methodist Sugarland

Sugar Land, Texas, United States

Inova Alexandria Hospital

Alexandria, Virginia, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

Providence Regional Medical Center

Everett, Washington, United States

Inland Imaging

Spokane, Washington, United States

CAMC

Charleston, West Virginia, United States

West Virginia University Heart & Vascular Institute

Morgantown, West Virginia, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Medical University of Vienna

Vienna, , Austria

CHRU jean Minjoz, Pôle cœur-Poumons

Besançon, , France

Hôpital Nord, APHM

Marseille, , France

Johannes Gutenberg Univeristy Mainz

Mainz, , Germany

Technical University Munchen

München, , Germany

University Medical Center Uterecht

Utrecht, , Netherlands

Swiss Cardiovascular Center

Bern, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

Acibadem University School of Medicine

Istanbul, , Turkey (Türkiye)

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Medway NHS Foundation Trust

Gillingham, , United Kingdom

Oxford University Hospitals

Headington, , United Kingdom

Royal Free

London, , United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

St. Mary's Hospital

London, , United Kingdom

Countries

United States; Austria; France; Germany; Netherlands; Switzerland; Turkey (Türkiye); United Kingdom

References

Sterling KM, Goldhaber SZ, Sharp ASP, Kucher N, Jones N, Maholic R, Meneveau N, Zlotnick D, Sayfo S, Konstantinides SV, Piazza G. Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE). Circ Cardiovasc Interv. 2024 Mar;17(3):e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448. Epub 2024 Jan 24.

Reference Type: DERIVED

PMID: 38264938 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BTG-001653-01

Identifier Type: -

Identifier Source: org_study_id